Sepsis and Myocarditis

July 14, 2025 updated by: Kedir Negesso Tukeni, Jimma University

Cardiac Manifestations of Sepsis and Its Association With Disease Outcome: A Prospective Cohort Study

This prospective cohort study aims to investigate the cardiac manifestations of sepsis and their influence on disease outcomes among adult patients at Jimma University Medical Center, Ethiopia, from May 2025 to May 2026. The research will include adults aged 18 and older with sepsis, categorizing them based on the presence or absence of cardiac involvement, which will be assessed through clinical symptoms, biomarkers, ECG, and echocardiographic findings. The study will evaluate the persistence of cardiac abnormalities, functional capacity, and survival over one year, utilizing structured data collection and advanced statistical methods, including survival analysis and regression techniques, to identify predictors of adverse outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Sepsis is a major cause of morbidity and mortality worldwide, frequently associated with multi-organ dysfunction, including the heart. Cardiac manifestations of sepsis, such as myocardial dysfunction and arrhythmias, significantly impact outcomes, yet their long-term implications remain inadequately studied, particularly in resource-limited settings like Ethiopia.

Objective: The objective of this study is to evaluate the cardiac manifestations of sepsis and their association with disease outcomes among adult patients with sepsis at Jimma University Medical Centre of Ethiopia.

Methodology: This prospective cohort study will be conducted at JUMC over one-year period, starting from May 2025 to May 2026. The study will be done on adult patients with no prior history of cardiac problems (aged ≥18 years) diagnosed with sepsis (including bacterial meningitis), and then grouped based on the presence (Group A) or absence (Group B) of sepsis-associated cardiac manifestations. Cardiac involvement will be defined using clinical symptoms, biomarkers (troponin, BNP), or abnormal ECG and echocardiographic findings. Outcomes, including persistence of cardiac abnormalities, functional capacity and survival, will be assessed and compared among both groups after one year of follow-up. Data will be gathered using a structured checklist and analysed using updated version software. The Kaplan-Meier curve and the log-rank test will be used to describe the survival function. Independent predictors of poor outcome will be identified by Cox regression analysis, and the model assumption will be checked by Schoenfeld and Cox-Snell residuals. The 95% confidence interval of the hazard ratio with a corresponding p-value of 0.05 will be used to declare statistical significance.

Study Type

Observational

Enrollment (Estimated)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
    • Oromia
      • Jimma, Oromia, Ethiopia, 378
        • Recruiting
        • Jimma University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Elsah T Asefa, MD, cardiologist
        • Sub-Investigator:
          • Mohammed M Abafogi, MD, cardiologist
        • Sub-Investigator:
          • Esayas K Gudina, MD, Internist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population will include all adult septic patients admitted to JUMC during the study period.

Description

Inclusion Criteria:

  • All adult patients aged 18 years and above diagnosed with sepsis admitted to Jimma University Medical Center during the study periods that are willing to participate and continue follow-up of their disease condition for at least one year.

Exclusion Criteria:

  • Patients with any kind of pre-existing established cardiac disease prior to their sepsis diagnosis and those who are not willing to participate or not willing to have follow-up of their disease condition for at least one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
This is a group of patients with the diagnosis of sepsis of any focus but without any signs/symptoms suggestive of cardiac involvement.
Other: Standard treatment for sepsis of any focus
This group of patients will be treated for the sepsis of any focus as per standard.
Group B

This is a cohort of patients with the diagnosis of sepsis of any foci and with the evidences of cardiac involvement defined as one or a combination of the following:

  • Clinical symptoms include chest pain, dyspnea, or arrhythmias.
  • Abnormal biomarkers, including troponins or BNP levels.
  • Evidence of cardiac dysfunction on ECG or echocardiography.

Both groups will be followed prospectively for 9 to 1 year to evaluate their outcomes.
Other: Treatment for the sepsis with standard management of cardiac failure
This group of patients will be treated for the sepsis and management of cardiac failure with additional supportive care cocktails based on the specific indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcomes of survival status and persistence or resolution of cardiac abnormalities.
Time Frame: at first, third and sixth- months post discharge

Outcomes will be assessed at the first, third, and sixth months post-discharge, with evaluations focusing on the following parameters:

  • Persistence or resolution of cardiac abnormalities
  • Survival status (alive or deceased)
  • Functional capacity and quality of life using standardized tools (KCCS).
at first, third and sixth- months post discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcomes of persistence or resolution of cardiac abnormalities, Survival status (alive or deceased) and functional capacity and quality of life using standardized tools (KCCS).
Time Frame: at sixth- months post discharge

Outcomes will be assessed at six months post-discharge, with evaluations focusing on the following parameters:

  • Persistence or resolution of cardiac abnormalities
  • Survival status (alive or deceased)
  • Functional capacity and quality of life using standardized tools (KCCS).
at sixth- months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jimma University

Collaborators

Ethiopian Society of Cardiac Professionals

Investigators

  • Study Chair: Nikolaus Alexander Haas, MD, Pediatician, Cardiologist, Ludwig Maximillians University of Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2025

Primary Completion (Estimated)

May 8, 2026

Study Completion (Estimated)

September 22, 2026

Study Registration Dates

First Submitted

July 14, 2025

First Submitted That Met QC Criteria

July 14, 2025

First Posted (Actual)

July 23, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JUIH/IRB/278/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The team is yet to decide whether to share IPD or not.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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